Table 4.
Calendar Days of Review by Different Stakeholders Requiring Response for Phase III Cooperative Group Trials Activated From 2000-2005
| CTEP / CIRB Review Time |
Cooperative Group Response Time |
Time Difference |
|||||
|---|---|---|---|---|---|---|---|
| Concept Review | Reviewer | n* | median | (range) | median | (range) | (coop minus CTEP) |
|
CTEP | 14 | 60 | (15 - 104) | 72 | (1 - 368) | 12 |
| CTEP | 4 | 48 | (19 - 66) | 36 | (22 - 84) | −12 | |
| Concept Re-review | CTEP | 3 | 6 | (1 - 6) | 17 | (1 - 56) | 11 |
| Protocol Review | |||||||
|
| |||||||
| Protocol Review Committee | CTEP | 33 | 32 | (5 - 69) | 32 | (1 - 188) | 0 |
| Protocol Re-Review | CTEP | 22 | 8 | (1 - 85) | 9 | (1 - 266) | 1 |
| CIRB Review | |||||||
|
| |||||||
| CIRB Review | CIRB | 43 | 29 | (5 - 55) | 21 | (2 - 83) | −8 |
| Protocol Re-review after CIRB Approval*** | CTEP | 19 | 12 | (1 - 32) | 17 | (1 - 140) | 5 |
| Amendments Prior to Activation | |||||||
|
| |||||||
| Protocol Re-Review | CTEP | 2 | 9 | (1 - 17) | 5 | (5 - 6) | −4 |
| CIRB Review | CIRB | 10 | 12 | (2 - 34) | 30 | (3 - 67) | 18 |
| Protocol Re-review after CIRB Approval*** | CTEP | 1 | 1 | (1 - 1) | 22 | (22 - 22) | 21 |
*
Sample size consists of the number of reviews that were required for the 28 clinical trials followed in the sample
**
The Concept Evaluation Panel was designed to provide a mechanism for quick feedback on new concepts. This process was rolled out during the sampling period - concepts for trials were either reviewed at the Concept Review Meeting or the Concept Evaluation Panel
***
Trials that require modifications after CIRB review require an additional consensus review by CTEP